N/A
N=1,509
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
Pregnancy · Neonates
Bottom Line
View on ClinicalTrials.gov: NCT00703014 ↗Enrolled (actual)
1,509
Serious AEs
36.6%
Results posted
Nov 2014
Primary outcome: Primary: Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) — 222; 214 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Corifollitropin Alfa 150 μg (Drug); 200 IU RecFSH/Follitropin beta (Days 1 to 7) (Biological); Placebo for Corifollitropin Alfa (Drug); Placebo for RecFSH/Follitropin beta (Drug); 200 IU RecFSH/Follitropin beta (Days 8 to hCG) (Biological); Ganirelix (Drug); hCG (Biological); Progesterone (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) |
222; 214 | — |
| PRIMARY Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) |
129; 117 | — |
| PRIMARY Number of Infants Born in Current Follow Up Trial Experiencing AEs |
164; 161 | — |
| PRIMARY Number of Infants in Current Follow Up Trial Experiencing SAEs |
106; 94 | — |
| PRIMARY Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. |
35.6; 34.4 | — |
| PRIMARY Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer. |
40.0; 36.6 | — |
Summary
The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).
Eligibility Criteria
Inclusion Criteria
- Participants who received at least one dose of either Corifollitropin Alfa or
Puregon®/Follistim® AQ Cartridge in Base Trial P05787 (NCT00696800);
- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Base Trial P05787 (NCT00696800);
- Able and willing to give written informed consent.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00703014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.